CN103781439A - Commissure modification of prosthetic heart valve frame for improved leaflet attachment - Google Patents
Commissure modification of prosthetic heart valve frame for improved leaflet attachment Download PDFInfo
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- CN103781439A CN103781439A CN201280043069.1A CN201280043069A CN103781439A CN 103781439 A CN103781439 A CN 103781439A CN 201280043069 A CN201280043069 A CN 201280043069A CN 103781439 A CN103781439 A CN 103781439A
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- lobule
- valve
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- cardiac valve
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
Embodiments of the present disclosure provide an improved support frame for a prosthetic heart valve. The support frame can include a plurality of diamond-shaped cells arranged in a plurality of circumferential rows. Three cells corresponding to the leaflet commissures can be configured as commissure tip cells, with elongated rounded portions rather than a diamond shape. The commissure tip cells can allow for insertion of leaflet tabs, thereby allowing the leaflets to be sutured outside of the valve. In this manner, the leaflet sutures can be removed from areas of high stress during physiologic loading. Thus, currently disclosed embodiments of a support frame can allow for use of thinner leaflet materials than possible with conventional prosthetic heart valves, without sacrificing valve durability in some embodiments.
Description
Related application
The application is according to 35U.S.C. § 119(e) priority of request to the U.S. Provisional Application number 61/509,889 of submitting on July 20th, 2011.
Technical field
The present invention relates to the embodiment of Cardiac valve prosthesis framework.
Background technology
It is existing for many years that Cardiac valve prosthesis is used for the treatment of valvular heart disease.Autologous cardiac valve (as aortic valve, valve of pulmonary trunk and Bicuspid valve) is guaranteeing that advancing of sufficient blood supply by cardiovascular system bringing into play vital effect aspect flowing.Can make these valvular functions not too effective because of congenital, inflammation or infection conditions.This type of may cause serious Cardiovascular Damage or death to the damage of valve.For many years, the method for authoritative this type of disease for the treatment of is, during cardiac operation under direct vision, valve is carried out to surgical repair or replacing, but this type of operation is easy to cause multiple complications.Work out recently and introduced and the intravascular technology of implanted prosthetic heart valve to there is less invasive mode than cardiac operation under direct vision with flexible conduit.
In this technology, artificial valve is arranged on flexible conduit end with the state of curling, and advances until valve arrives implantation position by patient's blood vessel.Subsequently, the valve at catheter tip place is for example by making, on it, balloon inflation of valve is housed and be expanded to its functional size in defective autologous position of valve.Alternatively, described valve can have elastic self-expanding stent or framework, and described support or framework are expand into functional size in the time that the delivery sheath of flexible pipe far-end is advanced at valve.
The inflatable valve of sacculus is preferred for changing the autologous valve of calcification conventionally, because catheter-balloon can apply enough expansive forces artificial valve's framework is anchored to around in calcified tissue.On the other hand, self-expanding valve is preferred for changing defective, non-narrow (non-calcification) autologous valve conventionally.A drawback relevant to implanting self-expanding valve be, in the time that operator starts to advance valve from the opening of delivery sheath, valve trend towards from the end of sheath very quick " jumping " go out; In other words, the outside bias force of valve framework trends towards making valve to discharge (eject) from the far-end of delivery sheath very fast, makes to be difficult to from sheath, to send valve and increased patient's wound risk in accurate and controlled mode.
Another problem relevant to percutaneous artificial valve being implanted to non-narrow autologous valve is that artificial valve may not organize towards periphery and apply the movement of enough power with opposing artificial valve.Conventionally, artificial valve's support must be equipped with extra grappling or attachment device, to assist that described valve is anchored to surrounding tissue.In addition, this type of assists anchoring device or the parts of the support of grappling valve conventionally extend into the non-affected areas of vascular system and fix so far, if this needs following the intervention, if for example artificial valve need to be removed in patient body, may cause complication.
The U.S. Patent Application No. 12/429 that on April 23rd, 2009 submits to, 040(is called " ' 040 application " herein) be incorporated herein by reference, it discloses design to solve the Cardiac valve prosthesis of these and other problems of the prior art and the embodiment of delivery device.In ' 040 application, in a disclosed embodiment, self-expanding valve comprises expandable stent, and the shape of described expandable stent is designed to, without the anchor or the retaining device that engage surrounding tissue, valve be remained in aortic valve, prevents its axially-movable.Can be set to allow valve controlled and accurate configuration from valve sheath for the delivery device of sending self-expanding artificial valve, to minimize or to prevent that described valve from jumping from valve sheath.
Fig. 1-2 illustrate one for as the embodiment of prior art support frame 12 of the disclosed Cardiac valve prosthesis of ' 040 application.Conventionally, ' 040 application discloses the prosthetic aortic heart valve with self-expanding support frame 12.Framework 12 comprises repetition, identical diamond-shaped element on the each position around framework, has this class unit of multirow (for example 3 row shown in Fig. 1-2).Valve can be radially compressed to compressive state to be delivered to allocation position by health and to may expand to its functional size at allocation position.
Support frame or support 12 supporting flexible lobule parts, for illustrated object, do not show lobule part.As shown, support 12 can be formed by framing components multiple longitudinal extensions, that be conventionally sinusoidal shape or pillar 16.Pillar 16 is made up of mutual bend pipe, and welds or be otherwise fixed to one another at node 18 places that formed by the summit (vertices) of contiguous bend pipe, to form network structure.Pillar 16 can be made up of suitable shape-memory material, as be called as the Nitinol of Nitinol, it allows valve to be compressed to the diameter reducing, to sent by delivery apparatus, and in patient body, expand into its functional size when valve is configured by delivery apparatus subsequently.If the valve inflatable valve that is sacculus, it is suitable for being curled on the inflatable sacculus of delivery apparatus and expand into its functional size by balloon inflation, and support 12 can be made up as rustless steel of suitable ductile material.
This support 12 has the end of inflow 26 and outflow end 27.The network structure being formed by pillar 16 comprise substantial cylindrical " top " or flow out end 20, outwardly-bent or expansion mid portion 22, and aduncate " bottom " or flow into end 24.Mid portion 22 is expected to be made into certain size and dimension, to extend in the valsalva's antrum of aortic root, once to implant, assist valve to be anchored on correct position.As shown, this network structure expects to have the curved shape along its whole length, its diameter increases gradually from flowing out end 20 to mid portion 22, subsequently, diameter reduces to flowing into the position of end 24 gradually from mid portion 22, subsequently diameter increase to be gradually formed on flow into that end 26 places stop gradually open part.
In the time of the swelling state of valve in it, mid portion 22 has diameter D1, flows into end 24 and has minimum diameter D2, flows into end 26 and has diameter D3, flows out end 20 and has diameter D4, and wherein D2 is less than D1 and D3, and D4 is less than D2.In addition, D1 and D3 expect to be greater than the diameter of the autologous ring that will implant valve.In this way, the overall shape of support 12 contributes to valve to remain on implantation position.More specifically, described valve can be implanted to (in illustrated example, being aortic valve) in autologous valve, make bottom part 24 be positioned at aortic valvular ring, mid portion 24 extends in valsalva's antrum above aortic valvular ring, and bottom is gradually opened end 26 and extended below aortic valvular ring.Valve resists the radially outer power of aortic valvular ring surrounding tissue by bottom part 24 and the geometry of support remains in autologous valve.Particularly, mid portion 24 and gradually open lower end 26 and extend radially outwardly and exceed aortic valvular ring, with resist better valve upstream and downstream direction (towards with away from aorta) axially displaced.Depend on the condition of autologous lobule, valve is configured in autologous ring conventionally, and autologous lobule is folded up and is compressed between the outer surface and valsalva's antrum wall of support 12.
The known artificial valve with self-expanding framework has extra anchoring device or frame part conventionally, and described anchoring device or frame part extend into the non-affected areas of vascular system and fix so far.Because the shape of support 12 contributes to keep valve, therefore do not need extra anchoring device and can minimize the total length L of support, to prevent that support top 20 from extending in aortal non-affected areas, or extend into the degree in aortal non-affected areas at least minimize top 20.
But the Frame Design shown in Fig. 1-2 does not allow optimum lobule adherence method.For example, the diamond-shaped element of framework 12 can not provide protection lobule suture to exempt from the heavily stressed method that imposes on lobule during the physiology of valve opens and closes.Due to the needed lobule adherence method of the disclosed diamond-shaped element of framework 12, therefore lobule suture may bear high-tension and tearable lobule after valve repetitive cycling at valve period of contact.Heavily stressed durability and the life-span of having limited valve of being born by lobule during use, especially being used thin tissue as Cor Sus domestica bag during as lobule material.On the other hand, for minimum human valve curl diameter to be more easily delivered to implantation position, use this type of lobulus gracilis material to expect.Therefore still need a kind of improvement Support frame for example using together with disclosed valve with artificial valve in ' 040 application.
Summary of the invention
Embodiments more of the present disclosure provide the framework using together with Cardiac valve prosthesis, and it can reduce the power that lobule and lobule suture bear during physiological stress.In one embodiment, the outflow end of contiguous framework is located and can be comprised circular protrusion corresponding to three unit of Colaesce, thereby forms three Colaesce top end unit, and those Colaesce top end unit are obviously different from other frame unit.Colaesce top end unit can allow to use the lobule on opposite end with tab, and it makes contiguous lobule tab through Colaesce top end unit through arranging, and is stitched together in valve outside.In this way, lobule suture removes from heavily stressed Colaesce region, thereby is protected away from described heavily stressed, thereby has reduced the risk that lobule material is torn.Therefore, disclosed and Cardiac valve prosthesis are optimally set to use together with Cor Sus domestica bag or other lobule material with lobulus gracilis material as the embodiment of the framework using together with disclosed valve in ' 040 application.
In some embodiments, lobule tab can be wrapped in bar, pin or be positioned at around other widget or insert of support frame outside.In addition, lobule tab can be sewn to around bar, pin or other widget.Therefore, lobule suture can be positioned at support frame outside, and away from heavily stressed Colaesce region.In some embodiments, at least a portion of support frame can be cloth-covered, so that lobule is attached to support frame outside.
Above-mentioned and further feature of the present invention and advantage are by more apparent according to the following detailed description continuing with reference to accompanying drawing.
Accompanying drawing explanation
Fig. 1 is the side view that can be used for the artificial valve's of the autologous aortic valve of changing heart prior art support frame.
Fig. 2 is the perspective view of the prior art support frame of the valve of Fig. 1.
Fig. 3 is according to the perspective view of the support frame for artificial valve of the present disclosure.
Fig. 4 is the perspective view of the support frame of Fig. 3, and lobule tab is placed through Colaesce top end unit.
Fig. 5 is the perspective view of the support frame of Fig. 4, and wherein lobule tab is fixed on pin around.
The specific embodiment
Unless context separately has clearly regulation, as the singulative being used in the application and claim " (a) ", " one (an) " and " as described in (the) " comprise plural form.In addition, term " comprises " and means " comprising ".Although convenient for statement, the operation of the exemplary embodiment of open method may be described with order specific, in succession, should be appreciated that disclosed embodiment can comprise the operating sequence that is different from disclosed specific, order in succession.For example, in some cases, the operation of in succession describing can rearrange or carry out simultaneously.In addition, the description being associated with a specific implementations provided in this article and be openly not limited to this embodiment, but can be applied to any embodiment disclosed herein.In addition, for the sake of simplicity, the not shown wherein disclosed system of accompanying drawing possibility, method and apparatus can be combined with other system, method and apparatus the variety of way of use.
Improved can expanded radially and the disclosed embodiment of the support frame of compression can use together with any artificial valve, as prosthetic aortic heart valve.Improve the embodiment of support frame and advantageously make lobule suture be positioned at valve outside, thereby lobule suture is removed from having heavily stressed region during physiological loads.Lobule suture is positioned over to valve outside (for example, support frame outside, but not lobule is fixed to support frame itself), can allows to use thinner lobule material, this operation can allow again artificial valve's the less delivery diameter of curling.
Fig. 3 shows an embodiment of improved support frame 30.Support frame 30 can comprise multiple strut members 32, and described strut member connects to form the network structure with inflow end 34 and outflow end 36 each other.In some embodiments, network structure can have an overall warp architecture, it divides 38 inwardly to attenuate from flowing into end 34 to reduced diameter portion, divides 38 to increase to expansion mid portion 40 diameters from reduced diameter portion, attenuates subsequently from mid portion 40 towards cancellated outflow end 36.Mid portion 40 can be made into certain size and dimension, to extend in the valsalva's antrum of aortic root, once to implant, assist valve to be anchored on correct position.Framework 30 can have the overall shape of the framework 12 being similar to shown in Fig. 1 and Fig. 2.
As shown, what support frame 30 can be by multiple longitudinal extensions, the framing component or the pillar 32 that are conventionally sinusoidal shape form.Pillar 32 is formed by mutual bend pipe, and welds or be otherwise fixed to one another at node 33 places that formed by the summit of contiguous bend pipe, to form network structure.In some embodiments, framework 30 can be formed as a single entirety.For example, in some embodiments, framework 30 can be used as single from metal tube cut get off.
The strut member 32 of support frame 30 can be arranged the inflatable cells 42 that forms the rhombus repeating, and has this class unit of multirow.In embodiment as shown in Figure 3, support frame 30 comprises four cell row, although may there be more or less cell row.Being positioned at contiguous the first row and two the middle row that flow into end 34 can be formed by the essentially identical unit 42 around the whole circumference of support frame 30.The fourth line that is positioned at contiguous outflow end 36 can comprise that three have difform Colaesce top end unit 44 with diamond-shaped element 42.Colaesce top end unit 44 separates around the circumference of the support frame 30 of contiguous outflow end 36, and diamond-shaped element 42 is between Colaesce top end unit 44.Colaesce top end unit 44 can be positioned at the Colaesce (point for example, being fixed together at contiguous lobule) corresponding to lobule.Therefore, having in the artificial valve of three lobules, support frame 30 can comprise three angled Colaesce top end unit 44 that separate.In artificial valve's the embodiment with more or less lobule, more or less Colaesce top end unit can lay respectively in described support frame.
Colaesce top end unit 44 can comprise elongated projection 46, and described projection 46 has two roughly straight axially extended pillars 47, and described pillar 47 links together in their upper end by the round tip 48 of contiguous outflow end 36.By comparison, diamond-shaped element 42 ends at 50 places, acute angle summit that contiguous strut member 32 is gathered together.As shown, the projection 46 in illustrated embodiment extends beyond the summit 50 of other unit at outflow end 36 places of framework 30.Compared with the support frame of prior art, elongated protrusion 46 and the round tip 48 of Colaesce top end unit 44 make lobule adhere to improvement, as more discussed in detail below with reference to Fig. 4.
When valve is during in swelling state, the mid portion 40 of expansion and the diameter that flows into end 34 can be set to be greater than the diameter of the autologous ring that will implant valve.In this way, the overall shape of support frame 30 contributes to valve to remain on implantation position.More specifically, described valve can be implanted to (in illustrated example, being aortic valve) in autologous valve, make the diameter parts 38 reducing be positioned at aortic valvular ring, mid portion 40 extends into valsalva's antrum in the position of a little higher than aortic valvular ring, and gradually opens to flow into and hold 34 in the slightly position extension lower than aortic valvular ring.Valve resists the radially export-oriented power of aortic valvular ring surrounding tissue by smaller diameter portion 38 and the geometry of support frame remains in autologous valve.Particularly, mid portion 40 and gradually open and flow into end 34 and extend radially outwardly and exceed aortic valvular ring, with resist better valve upstream and downstream direction (towards with away from aorta) axially displaced.Depend on the condition of autologous lobule, valve is configured in autologous ring conventionally, and autologous lobule is folded up and is compressed between support frame outer surface and valsalva's antrum wall.
The known artificial valve with self-expanding framework has extra anchoring device or frame part conventionally, and described anchoring device or frame part extend to the non-affected areas of vascular system and fix so far.Because the shape of support frame 30 contributes to artificial valve to remain on appropriate location, therefore do not need extra anchoring device and can minimize the total length L of support frame 30, to prevent that outflow end 36 from extending into aortal non-affected areas, or at least minimize the degree that end 36 extends into aortal non-affected areas that flows out.
As shown in Figure 4, artificial valve's supporting frame 30 can comprise multiple lobules that supported by support frame as described above 30 52.Multiple lobules 52 of described valve have inflow end 54 separately and flow out end 56.The inflow end 54 of lobule 52 can be fixed on support frame 30 inner sides, the position of the inflow end 34 of contiguous support frame.The suitable adherence method that lobule flows into end is described and illustrates in ' 040 application to be incorporated herein by reference.Conventionally, artificial valve can comprise annular enhancing skirt, and described annular enhancing skirt is fixed to the outer surface of the lobule inflow end on the stitching thread of adjacent valves inflow end.The inflow end of lobule assembly can be fixed on support frame by skirt being sewn onto on the pillar of support frame bottom, to skirt is clipped between framework and the bottom of lobule.
The outflow end 56 of lobule 52 limits the angled Colaesce separating 58 of the point meeting corresponding to each contiguous lobule 52.Each lobule 52 can comprise the relative lobule tab 60 that is positioned at lobule 52 arbitrary ends.Therefore, two lobule tab 60(for example, lobule tab 60 is from one of in two contiguous lobules 52) meet in each Colaesce 58.Every pair of lobule tab 60 can extend through each elongated protrusion 46 of each Colaesce top end unit 44.Each projection 46 is served as the Colaesce window frame part that lobule tab 60 extends through.After by Colaesce top end unit 44, lobule tab 60 can be sewn to together.In this way, lobule 52 can be connected to each other, and makes lobule suture be positioned at support frame 30 outsides, and therefore away from the high stress areas in support frame 30.
Lobule (for example can comprise any suitable biomaterial, pericardial tissue, as cattle, pig or Cor Equi bag), other biomembrane, bio-compatible synthetic material and fabric or other this type of material, be for example incorporated to by reference U.S. Patent number 6 herein, those described in 730,118.
Fig. 5 has shown an embodiment of artificial valve 100, and it has shown the inflow end 54 of lobule 52 and flowed out end 56 how to be connected to support frame 30.The contiguous end 56 of flowing out, lobule tab 60 can be wrapped in around for example cloth-covered pin or wedge 62.In some embodiments, through after Colaesce top end unit 44, lobule tab 60 can be sewn to together around widget, described widget for example cloth-covered pin 62, cloth-covered Mylar insert, thin polyester insert or little bar or the pin be made up of metal and/or plastics.As shown, bar or pin 62 can have very little diameter and be positioned at support frame 30 outsides, thereby do not limit the amount that can be curled the support frame for sending.After parcel pin 62, lobule tab 60 can stitch together each other by one or more lobule sutures 64.In some embodiments, pin 62(for example, cloth-covered pin) can for example be connected to support frame 30 by single suture, to guarantee that pin 62 can be from lobule tab 60 superior displacements.For example, in some embodiments, at least a portion of support frame 30 can be cloth-covered, and one or more suture can be fixed to the fabric that encases support frame 30 by the fabric that encases bar or pin 62.
Because lobule suture 64 can be positioned at the outside of support frame 30 and the outside of cloth-covered pin or insert 62, therefore lobule suture can be positioned at the position away from enough from the high stress areas of lobule, so that fully protection avoids imposing on the stress of lobule during physiological stress.This placement can advantageously allow for example to use, compared with lobulus gracilis material (Cor Sus domestica bag), describedly may be not suitable for because of the risk of lobule suture tears lobule material using in prior art framework compared with lobulus gracilis material.
Fig. 5 also illustrates an embodiment that the inflow end 54 of lobule 52 is fixed to support frame 30.For example, artificial valve 100 can comprise that annular strengthens skirt 74, and the stitching thread that described annular enhancing skirt 74 is following the lower knuckle edge track of lobule is fixed on the outer surface of inflow end 54 of lobule 52.By skirt 74 being sewn onto on the pillar 32 of support frame 30, annular strengthens skirt 74 can be fixed to again support frame 30.In some embodiments, lobule assembly can also comprise that the inside on the inner surface of the inflow end 54 that is fixed to lobule 52 strengthens bar.This skirt can comprise suitable tear-resistant fabric, for example PET or Dacron fabric.
In some embodiments, the part of at least a portion of support frame 30 and/or lobule tab 60 can be encased by for example Dacron of bag fabric, so that lobule adheres to.For example, the cloth-covered pin 62 that lobule tab 60 wraps up and/or the inflow end 54 of lobule 52 can be stitched on the bag fabric of parcel support frame 30.In some embodiments, Colaesce top end unit 44 can be cloth-covered so that lobule adheres to.In some embodiments, whole support frame 30 can be cloth-covered.In some embodiments, lobule tab 60 can for example, be reinforced with one or more enhancement layers (tissue layer).Be incorporated to by reference U.S. Provisional Patent Application herein number 61/472,083 and 61/386,833 disclose will bag fabric applications in suitable material and the method for for example support frame 30 of Support frame.Be incorporated to by reference U.S. Provisional Patent Application herein number 61/390,107 and disclose other technology that lobule tab is fixed to the Colaesce window frame part of the outside, chamber of framework.In application number 61/390,107, disclosed technology can be used for lobule tab 60 to be fixed on frame part 44.
Due to the geometry of support frame, the disclosed embodiment of the improved support frame using together with artificial valve is particularly suitable for changing non-narrow aortic valve, and it is not grappling artificial valve and the autologous valve of calcification conventionally.Desirably, support does not comprise extra for assisting anchoring device or the frame part of valve in correct position.Therefore, be implantable valve without the non-affected areas of contact vascular system, thereby if need to get involved in the future time, prevent or at least minimize complication.In optional embodiment, disclosed support frame and artificial valve can be suitable for being configured in the autologous valve of heart, or are suitable for changing other valve in health, for example vein valve.
Disclosed improved support frame and overall artificial valve can be radially compressed to compressive state, to be delivered to allocation position by health and to expand into functional size on allocation position.Be incorporated to by reference in ' 040 application herein and describe in detail and be specially adapted to self-expanding or the dermal delivery of the inflatable valve of sacculus and the device of implantation.Conventionally, artificial valve can be implanted by Retrograde, the valve that is wherein arranged on delivery apparatus far-end with the state of curling is introduced in body by for example femoral artery, and advance to heart by aortic arch, as being incorporated to by reference U.S. Patent Publication herein number 2008/0065011, it is further elaborated.
In view of the many possible embodiment that principles of this disclosure may be used on, therefore should be appreciated that illustrated embodiment is the preferred embodiments of the present invention and should not be used for limiting the scope of the invention.On the contrary, scope of the present invention is defined by the appended claims.I am therefore claimed all from my invention in the scope and spirit of these claim.
Claims (20)
1. the Cardiac valve prosthesis for implanting on the implantation position with ring, described valve comprises:
Radially inflatable and compressible support frame, it comprises multiple cancellated strut members that are interconnected with one another to form, described network structure comprises inflow end, outflow end and multiple inflatable cells row; And
Multiple lobules, it has inflow end separately and flows out end, the described outflow end of described lobule is defined as the Colaesce of angle intervals and comprises and be positioned at the first end of described lobule and the relative lobule tab at the second end place, arrange described lobule, so that the described lobule tab of the contiguous lobule of alignment, to form a pair of lobule tab in each comissure, and wherein the every pair of lobule tab extends through in one of described inflatable cells row inflatable cells separately.
2. cardiac valve as claimed in claim 1, wherein said multiple cell row comprises the outflow row at the described outflow end place of described framework, some in the described unit of described outflow row comprise elongated projection, and every pair of lobule tab extends through described elongated projection.
3. cardiac valve as claimed in claim 1, wherein said elongated projection extends beyond the end of the adjacent unit in described outflow row.
4. cardiac valve as claimed in claim 1, wherein said lobule comprises Cor Sus domestica bag.
5. cardiac valve as claimed in claim 1, further comprises the lobule suture that at least one is fixed together every pair of lobule tab, and described lobule suture is positioned at described support frame outside.
6. cardiac valve as claimed in claim 1, further comprises at least one bar or pin, and described bar or pin are positioned at described support frame outside and are adjacent to each Colaesce, make every pair of lobule tab be set to wrap up described bar or pin.
7. cardiac valve as claimed in claim 6, wherein said bar or pin are cloth-covered, and are fixed on described support frame by the one or more pin sutures that are positioned at described support frame outside.
8. cardiac valve as claimed in claim 1, at least a portion of wherein said support frame is cloth-covered.
9. cardiac valve as claimed in claim 1, wherein said network structure comprises the mid portion of expansion, the mid portion of described expansion has the first diameter at primary importance place, described mid portion is tapered in the direction towards described inflow end, has second, the inflow end of minor diameter more to be formed on second position place.
10. cardiac valve as claimed in claim 1, wherein said cancellated described inflow end has gradually opens part, the described diameter of gradually opening part increases to the 3rd position at the described cancellated described inflow end place with the 3rd diameter from the described second position, and described the first diameter and described the 3rd diameter are greater than described Second bobbin diameter.
11. cardiac valve as claimed in claim 1, wherein said mid portion is tapered in the direction towards described outflow end, to form the outflow end with the 4th diameter that is less than described the first diameter.
12. cardiac valve as claimed in claim 1, the described inflow end of wherein said lobule is fixed to the inner side of the described support frame of the described inflow end that approaches described support frame.
13. support frames for Cardiac valve prosthesis, it comprises:
Radially inflatable and compressible framework, it comprises multiple cancellated strut members with inflow end and outflow end that interconnect to form;
Wherein said strut member forms inflatable cells, and described framework comprises multiple cell row; And
Wherein the described row of contiguous described outflow end comprises multiple Colaesce top end unit with elongated protrusion, and two substantially straight axially extended pillars that described projection is connected by round tip form.
14. support frames as claimed in claim 13, wherein said network structure has the shape of overall bending, the shape of described overall bending is held reduced diameter portion inwardly to divide from described inflow and is tapered, the mid portion that diameter is assigned to expansion from described reduced diameter portion increases, and is tapered towards described cancellated described outflow end direction from described mid portion subsequently.
15. support frames as claimed in claim 13, wherein said strut member is formed by shape-memory material.
16. support frames as claimed in claim 13, it has isolated three Colaesce top end unit around the circumference of the described support frame of contiguous described outflow end.
17. support frames as claimed in claim 13, wherein said framework forms single entirety.
18. support frames as claimed in claim 17, wherein said framework gets off from metal tube cut.
19. support frames as claimed in claim 13, at least a portion of wherein said framework is encased by fabric.
20. support frames as claimed in claim 13, wherein said projection extends beyond the described unit in the described cell row of the described outflow end of contiguous described framework in outflow direction.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161509889P | 2011-07-20 | 2011-07-20 | |
| US61/509,889 | 2011-07-20 | ||
| US13/552,520 | 2012-07-18 | ||
| US13/552,520 US20130023984A1 (en) | 2011-07-20 | 2012-07-18 | Commissure modification of prosthetic heart valve frame for improved leaflet attachment |
| PCT/US2012/047450 WO2013013074A2 (en) | 2011-07-20 | 2012-07-19 | Commissure modification of prosthetic heart valve frame for improved leaflet attachment |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN103781439A true CN103781439A (en) | 2014-05-07 |
Family
ID=47556314
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201280043069.1A Pending CN103781439A (en) | 2011-07-20 | 2012-07-19 | Commissure modification of prosthetic heart valve frame for improved leaflet attachment |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US20130023984A1 (en) |
| EP (1) | EP2734154A2 (en) |
| CN (1) | CN103781439A (en) |
| CA (1) | CA2842172A1 (en) |
| WO (1) | WO2013013074A2 (en) |
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| WO2018121341A1 (en) * | 2016-12-30 | 2018-07-05 | 先健科技(深圳)有限公司 | Heart valve prosthesis device and leaflet and stent body thereof |
| CN108430394A (en) * | 2016-12-15 | 2018-08-21 | 美利奴生命科学有限公司 | Artificial valve |
| WO2018184226A1 (en) * | 2017-04-07 | 2018-10-11 | 上海甲悦医疗器械有限公司 | Prosthetic valve and prosthetic valve implanting method |
| CN109893298A (en) * | 2014-12-19 | 2019-06-18 | 国立研究开发法人国立循环器病研究中心 | Artificial valve |
| CN110868962A (en) * | 2017-05-15 | 2020-03-06 | 爱德华兹生命科学公司 | Commissure formation devices and methods for prosthetic heart valves |
| CN111132636A (en) * | 2017-09-27 | 2020-05-08 | W.L.戈尔及同仁股份有限公司 | Prosthetic valves with expandable frames and associated systems and methods |
| CN112996461A (en) * | 2018-11-14 | 2021-06-18 | 爱德华兹生命科学公司 | Prosthetic heart valve with commissure support elements |
| US11154397B2 (en) | 2017-10-31 | 2021-10-26 | W. L. Gore & Associates, Inc. | Jacket for surgical heart valve |
| US11439502B2 (en) | 2017-10-31 | 2022-09-13 | W. L. Gore & Associates, Inc. | Medical valve and leaflet promoting tissue ingrowth |
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| US11497601B2 (en) | 2019-03-01 | 2022-11-15 | W. L. Gore & Associates, Inc. | Telescoping prosthetic valve with retention element |
| US11826248B2 (en) | 2012-12-19 | 2023-11-28 | Edwards Lifesciences Corporation | Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet |
| US11872122B2 (en) | 2012-12-19 | 2024-01-16 | Edwards Lifesciences Corporation | Methods for improved prosthetic heart valve with leaflet shelving |
| US11896481B2 (en) | 2012-12-19 | 2024-02-13 | Edwards Lifesciences Corporation | Truncated leaflet for prosthetic heart valves |
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- 2012-07-19 CN CN201280043069.1A patent/CN103781439A/en active Pending
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| US11896481B2 (en) | 2012-12-19 | 2024-02-13 | Edwards Lifesciences Corporation | Truncated leaflet for prosthetic heart valves |
| US11872122B2 (en) | 2012-12-19 | 2024-01-16 | Edwards Lifesciences Corporation | Methods for improved prosthetic heart valve with leaflet shelving |
| US11826248B2 (en) | 2012-12-19 | 2023-11-28 | Edwards Lifesciences Corporation | Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet |
| US11471276B2 (en) | 2014-09-15 | 2022-10-18 | W. L. Gore & Associates, Inc. | Prosthetic heart valve with retention elements |
| CN109893298A (en) * | 2014-12-19 | 2019-06-18 | 国立研究开发法人国立循环器病研究中心 | Artificial valve |
| CN108430394A (en) * | 2016-12-15 | 2018-08-21 | 美利奴生命科学有限公司 | Artificial valve |
| WO2018121341A1 (en) * | 2016-12-30 | 2018-07-05 | 先健科技(深圳)有限公司 | Heart valve prosthesis device and leaflet and stent body thereof |
| CN108261255A (en) * | 2016-12-30 | 2018-07-10 | 先健科技(深圳)有限公司 | Artificial heart valve film device and its leaflet and rack body |
| CN108261255B (en) * | 2016-12-30 | 2020-12-25 | 先健科技(深圳)有限公司 | Artificial heart valve device and valve leaf and support main body thereof |
| US11278399B2 (en) | 2016-12-30 | 2022-03-22 | Lifetech Scientific (Shenzhen) Co., Ltd | Heart valve prosthesis device and leaflet and stent body thereof |
| WO2018184226A1 (en) * | 2017-04-07 | 2018-10-11 | 上海甲悦医疗器械有限公司 | Prosthetic valve and prosthetic valve implanting method |
| CN110868962B (en) * | 2017-05-15 | 2022-04-26 | 爱德华兹生命科学公司 | Commissure formation devices and methods for prosthetic heart valves |
| CN110868962A (en) * | 2017-05-15 | 2020-03-06 | 爱德华兹生命科学公司 | Commissure formation devices and methods for prosthetic heart valves |
| CN111132636B (en) * | 2017-09-27 | 2022-04-08 | W.L.戈尔及同仁股份有限公司 | Prosthetic valves with expandable frames and associated systems and methods |
| US11857412B2 (en) | 2017-09-27 | 2024-01-02 | Edwards Lifesciences Corporation | Prosthetic valve with expandable frame and associated systems and methods |
| CN111132636A (en) * | 2017-09-27 | 2020-05-08 | W.L.戈尔及同仁股份有限公司 | Prosthetic valves with expandable frames and associated systems and methods |
| US11986387B2 (en) | 2017-09-27 | 2024-05-21 | Edwards Lifesciences Corporation | Prosthetic valves with mechanically coupled leaflets |
| US11439502B2 (en) | 2017-10-31 | 2022-09-13 | W. L. Gore & Associates, Inc. | Medical valve and leaflet promoting tissue ingrowth |
| US11154397B2 (en) | 2017-10-31 | 2021-10-26 | W. L. Gore & Associates, Inc. | Jacket for surgical heart valve |
| US11974916B2 (en) | 2017-10-31 | 2024-05-07 | Edwards Lifesciences Corporation | Jacket for surgical heart valve |
| CN112996461A (en) * | 2018-11-14 | 2021-06-18 | 爱德华兹生命科学公司 | Prosthetic heart valve with commissure support elements |
| CN112996461B (en) * | 2018-11-14 | 2024-02-27 | 爱德华兹生命科学公司 | Prosthetic heart valve with commissure support elements |
| US11497601B2 (en) | 2019-03-01 | 2022-11-15 | W. L. Gore & Associates, Inc. | Telescoping prosthetic valve with retention element |
Also Published As
| Publication number | Publication date |
|---|---|
| US20130023984A1 (en) | 2013-01-24 |
| WO2013013074A3 (en) | 2013-03-21 |
| CA2842172A1 (en) | 2013-01-24 |
| WO2013013074A2 (en) | 2013-01-24 |
| EP2734154A2 (en) | 2014-05-28 |
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Application publication date: 20140507 |